CLASS III Drug recall · Reported 23 Nov 2016 · FDA Enforcement Report
Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot recalled
GSK Consumer Healthcare is recalling Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, distributed nationwide in the US. The recall was initiated on 18 Oct 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0142-2017
- FDA event ID
- 75482
- Recalling firm
- GSK Consumer Healthcare, Warren, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Oct 2016
- FDA classified
- 17 Nov 2016
- Reported
- 23 Nov 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
Timeline
| 18 Oct 2016 | Recall initiated by company | |
| 17 Nov 2016 | Classified by FDA | +30 days |
| 23 Nov 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating "use for the cure of most jock itch" rather than "use for the cure of most athlete's foot".
Product as listed by the FDA
Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel Laboratories, Inc., Research Triangle Park, NC 27709, UPC 0 73462 15065 1; NDC 0145-1506-01
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating "use for the cure of most jock itch" rather than "use for the cure of most athlete's foot".
Which lots are affected?
Lot #: 5M02ST*, 5M03ST*, 5M04ST*, Exp 10/17; 5P01ST, 5P01STA, 5P02ST, 5P03ST, 5P04ST, 5P05ST, Exp 11/17; 6C03ST, 6C04ST, 6C05ST, 6C06ST, 6C07ST, Exp 02/18 *Lots 5M02ST, 5M03ST, and 5M04ST contain the NDC code error only on front label, back label is correct.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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